Progression-free Survival after Minimally Invasive Surgical Microwave Ablation plus Durvalumab (MEDI4736) and Tremelimumab for Unresectable Non-metastatic Locally Advanced Pancreatic Cancer. MIMIPAC trial. - MIMIPAC

ZLeuven0 个研究点目标入组 20 人开始时间: 2019年12月23日最近更新: 2024年2月19日

适应症

试验速览

暂无简介。

•Patients with unresectable non-metastatic Locally Advanced Pancreatic Cancer (LAPC) defined according to NCCN guidelines Version 2.2017
•Histologically proven adenocarcinoma of the pancreas located in the head, body or tail
•LAPC tumor greatest diameter maximum 5 cm
•Male or female, age 18 years and older, ECOG PS 0-1
•Life expectancy of at least 12 weeks
•Only patients who did not receive chemotherapy for their PC are allowed
•Patients without distant organ metastases on conventional diagnostic imaging
•Pre-operative biliary drainage for obstructive jaundice is allowed, but the type of biliary stent is standardized in all jaundiced patients
•Patients fit for MIS-MWA
•Able to receive Durvalumab and Tremelimumab.
•Patients with good liver and renal function and with good hematology
•Effective contraception for both male and female patients if applicable. Women of childbearing potential must have negative blood pregnancy test at screening visit.
•Written informed consent (+ optional for TR) must be given according to ICH/GCP and national/European regulations
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 10
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

•Metastatic PC on conventional diagnostic imaging or staging laparoscopy
•LAPC tumor greatest diameter is larger than 5 cm
•Borderline or resectable PC defined according to the NCCN guidelines version 2.2017
•Systemic chemo(radio)therapy is not allowed before MIS-MWA
•Major surgical procedure within 28 days prior to the first dose of investigational products
•Classic contraindications for PDL and CTLA antibodies

发起方

ZLeuven